510(k) K131948 ยท HCG Device, Neurovascular Embolization
MICROPLEX COIL SYSTEM (MCS)
| Applicant | MicroVention, Inc., Tistin CA, US |
| Decision | Substantially Equivalent, Oct 4, 2013 |
| Received | Jun 27, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131948
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620 Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HC Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx, REF numbers 180520HC-R-V and 181230HC-R-V.
Product Usage: The MCS is also int Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 10051 Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451 Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100 Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-V.
Product Us Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 10061 Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC03 Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 100102HS-V, 100103HS-V, 100104HS-V, 100151HS-V, 100152HS Terminated |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.